Musings in the life of an internist, cardiologist and cardiac electrophysiologist.

Saturday, August 03, 2013

A Case of Fraud

He was a slender-framed man, mid- to late-sixties, with a kind of ridden-hard-put-away-wet complexion. It was clear the years had not always been good to him, but being the kind soul that he was, he had plenty of friends. It was a beautiful summer day to spend with friends for a barbecue, but he arrived feeling puzzled why he collapsed at home earlier in the day.

He stopped at the keg and poured himself a beer in a red solo cup, and as he approached his friends with a smile, he did it again, this time which such gusto that his beer went flying and the thud he made when he hit the ground made everyone gasp. He laid motionless for a moment face down on the ground while his friends rushed to his aid. An ambulance was summoned as others rolled him over onto his back. He began to move - slowly at first - then more purposefully. As sirens approached, he asked his friends, "What just happened?'

A bit later, he arrived in the Emergency Room, awake, alert, pleasant, and seemed - on the surface at least - fine. His vital signs were normal - perfect, in fact. About the only things immediately noticeable was his thin frame, his coffee-stained teeth, and a clump of grass in his hair that the nurse kindly removed. He was placed in the gurney, an IV was started, blood was drawn, and EKG was performed as a few "hellos" and "what happeneds" were exchanged, then off to the CT scanner he went to rule out an intracranial process. It was normal and his EKG showed a first-degree AV block and incomplete left bundle branch block without evidence of acute injury or prior heart attack.

He returned from the CT scanner and was examined a bit more closely. A loud, blowing, holosystolic murmur was heard by the medical student. In fact, it was loud enough to create a "thrill" - a palpable vibration on the thin man's chest. The medical student seemed pleased with himself, then ordered his first echo which revealed a relatively weak heart with a few chamber walls that didn't move so well, and a very leaky heart valve. He was admitted, placed on telemetry, and seen by a cardiology consultant. Closer inspection of the echo revealed a dilated left ventricle with a posterior wall motion defect and a central jet of mitral regurgitation large enough to fill the left atrium with a mosaic of color that extended to the pulmonary veins. It was clear he'd need surgery, so a diagnostic catheterization was performed. It showed three-vessel coronary artery disease and confirmed severe mitral regurgitation. His medications were adjusted and surgery consulted. A date for surgery was arranged at the neighboring hospital the following week and all seemed well.

But he had different plans.

As he settled down for dinner, he felt suddenly flushed, lightheaded, and broke out in a sweat. With that, the telemetry alarm sounded and soon the room was full of people, crash carts, and hysteria. His dinner table was shoved aside and he was laid flat as his chest was made bare. He didn't know what all the excitement was about, but heard the words "He's fibrillating!" and then felt the cool metal discs covered with cold goo applied to his chest. "What are you do...?" and with that, he felt his chest and arms jerk violently just before he passed out. "Shit, he's still fibrillating!" someone shouted. So they charged again and shocked him, this time to sinus rhythm. The anesthesiologists who had arrived on the scene of the arrest took no chances: he was intubated and expeditiously transferred to the ICU.

Upon arrival to the ICU, the patient was clearly recovering well and quickly extubated the next day. Beta blockers were administered additional anti-anginal and anticoagulants given. Once stabilized, he was transferred to the surgical hospital and underwent urgent bypass surgery with mitral valve replacement. At the time, the surgeon could see considerable endocardial scar.

His recovery was uncomplicated, but four days after his surgery, he still required external pacing. Cardiac electrophysiology was consulted to consider an ICD placement, given his history of sinus node dysfunction, cardiac arrest, diminished LV function, and the visible presence of endocardial scar during surgery.

The electrophysiologist reviewed the case and noted that the patient's original in-house arrhythmia at the time of his "arrest" was actually an organized, rapid ventricular tachycardia that was then shocked into ventricular fibrillation by an asynchronous defibrillation attempt. An echocardiogram performed post-operatively showed a very low EF of 23%, but a good repair of his valve and he appeared to be progressing quite nicely in his cardiac rehabilitation. Still, it was felt he was at high risk for another arrhythmic event, so a wearable defibrillator as ordered as they waited out his conduction system a bit longer to see if it would recover function. It never did.

So 10 days later after the sinus node failed to recover, the electrophysiologist had a choice: implant a pacemaker, or implant a defibrillator? It shouldn't be a difficult decision in this case, should it?

But the electrophysiologist knew he'd be committing fraud if he implanted a defibrillator and billed Medicare for the device and procedure. That's because Medicare's 2005 National Coverage Decision requires doctors to wait 90 days and then "reassessing" the patient's heart function later before implanting a defibrillator once the heart is revascularized surgically.

But he wondered about the extra risk of infection created by two surgeries (one for a pacemaker and one later to upgrade the device to an implantable defibrillator) instead of one. He wondered if anyone ever considered the frequent venous occlusions that preclude later upgrade of pacemakers to defibrillators via the same side as the original pacemaker implant. Even if he implanted a defibrillator lead at the same time he implanted the original pacemaker, wouldn't he be committing fraud if a more expensive defibrillator lead were billed to Medicare instead of a pacemaker lead? And what about the added cost, inconvenience, and poor compliance rates of patients issued wearable defibrillators as they wait out the 90-day waiting period for an ICD? Finally, what are the ethics of asking his patient to sign a form that obligates the patient to pay for his defibrillator if Medicare fails to do so when the actual costs involved to implant a defibrillator are closely held institutional secrets?

9 comments:

I know that anything and probably most things that you read in a blog only represent truth and do not necessarily tell the real story. However, the fact that you published this has me worried about you.

Have been there and done that on multiple occasions. Not only do we need to account to Medicare for these implants, but the same applies to the hospital. We have to do paperwork justifying the implant. The hospital will not submit the bill to CMS until they verify the implant was "indicated". However, the CMO just asks that we do as you did, document clinical medical necessity in full detail.

Since my husband's entry into the whirlwind world of Afib, I have read this blog religiously. This particular entry will give other doctor's courage to make those decisions which align with their consciences as opposed to the rigid, often nonsensical standards of care, will give patients a nuanced look into the decisions their doctors confront daily, thereby leading, I hope, to a less litigious, more compassionate/empathetic patient/doctor relationship, and give Medicare and other insurers just a glimpse at how onerous the business model system they have invented has become. They have created a monster with untold consequences for doctors and patients. One can only hope the ACA derails/implodes and intelligent minds set about rewriting. One hopes they would then invite input from those on the medical front lines and not from those who have not practiced medicine in years. Finally, this blogger covers all the bases as far as I can tell: he documented his rationale for his professional medical opinion in this case and most assuredly informed the patient of potential financial liability in the case of denial of payment. He is also obviously a man of prayer, which will necessarily lead to a well-formed conscience and a well-tested fund of trust in Providence.

I've come across similar difficult dilemmas in the past as well, but really do think this particular case is justifiable.

Because the patient had a documented episode of sustained VT, he is best classified as a secondary prevention case and fits into catagory B. 2. in the NCD. The post revascularization waiting period applies only to primary prevention cases (where it matches the inclusion criteria of the SCD-HeFT and MADIT 2 trials).

The 2005 NCD ( http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110&ncdver=3&IsPopup=y&NCAId=102&NcaName=Implantable+Defibrillators+-+Clinical+Trials&bc=AAAAAAAAIAAA& ) does not mandate delays for secondary prevention cases. Note the wording under section 8 in which implant delays are specifically established only for primary prevention (B. 3-8).

Key for your patient is establishing that the VT event was not due to transient and reversible causes (i.e. MI or electrolyte imbalance). Your patient fits well into section B. 2. which allows ICD for "Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause (effective July 1, 1999)."

In your narrative, you make the case that there was no acute MI and I see no other transient and reversible causes listed. Had there been a modest troponin bump or mild hyperkalemia post arrest (as we've all commonly seen), then the case might be more difficult to justify to a reviewer.

Take a look and see if you agree with me. If you rewrote the scenario by taking out the sustained VT, or adding in an MI or transient and reversible cause, the dilemma would have been more challenging.

None is this is meant to take away from the challenges that the rigidity of the NCD creates. No doubt, this is not good for patients or doctors. I agree with the overarching sentiments. We are obliged to do what is right for our patients.

Thanks for your comments. They are certainly a helpful perspective from a seasoned veteran.

But a few words about the CMS National Coverage Decision you referenced: (1) it is antiquated, (2) it has not been kept up to date with new innovations in ICD therapy, and (3) it appears there is not going to be any effort by CMS to do so. As a result, doctors are increasingly exposed to legal risk for fraudulently billing Medicare if they are not followed to the letter of the law.

What are we to conclude from this?

It is becoming abundantly clear that conflicts between the santity of human life will confront the government's unwillingness to pay for procedures. No where is this more clear than with approval of payment for the implantation of an ICD, which might run in excess of $200K for the procedure at some instituions. As a result, doctors who strive to provide state-of-the-art care to their patients will continue to confront similar ethical dilemmas that risk their legal standing (and credentials) as they care for their sickest arrhythmia patients.

By publishing this case scenario, my hope was to draw attention to these ethical dilemmas that are becoming increasingly prevalent in medicine as a result of these outdated, inconsistent, and incomplete coverage decisions, guidelines for care, and "appropriateness use" criteria. Further, the potential for legal action against physicians y imposes real fear for doctors if they stray at all from these outdated decisions. This fear is to the point where it might do actual harm - and even cause death - to patients who are left without appropriate treatment as a result.

Concerning the case at hand: There are plenty of areas where a federal prosecutor or their "expert" witness might disagree with your interpretation that this "new" symptoms of syncope and VT was not from a "transient or reversible cause,' especially in the setting of ischemic CAD and severe, uncorrected MR that underwent revascularization and valve repair. I agree with you that, ethically and on the basis of where medicine stands today, the ICD was justified, but will the Department of Justice officials who know little about the subtlties you describe but follow "the written letter of the law" bend to permit such an implant? Perhaps.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.